Pharmacokinetics of Caspofungin in Burn Patients — Caspo-brûlés  

Thermal Injury Clinical Trial

Official title: Pharmacokinetics of Caspofungin in Burn Patients

Status Completed

Clinical Trial Summary

Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. Several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. However, no pharmacokinetic data are available of caspofungin in the burn population. The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.

Clinical Trial Description

The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.). Blood samples are drawn just before administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after administration. Caspofungin plasma concentrations are measured by liquid-chromatography spectrometry mass tandem.The primary end-points are :

• area under the curve of caspofungin plasma concentrations over 24 hours

• mean peak level and trough concentration (24 hours after dosing)

The secondary end-points are :

• mean total clearance

• mean distribution volume These parameters will be compared to those usually observed in non burn patients. The optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thermal Injury

• NCT number: NCT00748345
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2009
• Completion date: December 2010